BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2770302 · Received October 1, 2012

    Report

    Report Number
    1828100-2012-01281
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 6, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT CUSTOMERS ARE CONFUSED ABOUT THE EXPIRATION DATE INDICATED ON THE PRODUCT LABELING OF SARNS LEVEL SENSOR PADS II. SEEMINGLY THE FORMAT IS MM/DD/YY. THERE SEEMS TO BE SOME CONFUSION, ESPECIALLY WHEN THE DAY IS < OR EQUAL TO TWELVE (12). THERE IS SOME CONFUSION ABOUT WHAT IS THE MONTH OR DAY. (B)(4) STIPULATES EXPIRATION DATES ARE TO BE INDICATED IN THE FOLLOWING FORMAT: YYYY/MM/DD. THE CUSTOMER WILL BE KEEPING THE PRODUCT INVOLVED IN THIS COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 195240 129954

    Patients

    Seq Age Sex Outcome Treatment
    1